A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00493688
First received: June 27, 2007
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.

In this proposed study researchers will:

  1. Measure preoperative energy reserve capacity (fitness)
  2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Condition Intervention
Abdominal Cancer
Pelvic Cancer
Other: Cardiopulmonary Exercise Testing (CPET)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Perioperative Risk + Postoperative Morbidity [ Time Frame: Baseline + 30 days postoperatively monitoring for morbid events ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiopulmonary Exercise Testing (CPET) Other: Cardiopulmonary Exercise Testing (CPET)
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Detailed Description:

Participants in this study are already scheduled to have major abdominal or pelvic cancer surgery.

If you agree to take part in this study, you will exercise on a stationary bicycle, while breathing through a mouthpiece and wearing a nose clip, before your surgery. You will be asked to pedal at 60 revolutions per minute as the resistance to pedaling gradually increases. During your pedaling, your vital signs will be monitored using a blood pressure cuff, electrocardiogram (ECG) leads (to measure the electrical activity of the heart), and a pulse oximeter. The mouthpiece is used to analyze the inhaled vs the exhaled breaths. The nose clip is to remind you to breathe through the mouthpiece. This will help researchers learn the level of oxygen uptake during exercise, before surgery.

You will stop the test when you become tired. The length of this test will vary from participant to participant.

You will be asked questions to help rate how well you are able to move physically, based on two independent forms. These forms will rate your physical status according to 2 scales ( 0 to 4, and 10 to 100, respectively), with high scores meaning less difficulty with physical movement and lower scores meaning you have more difficulty with physical movement.

You will be asked to complete a brief form asking 12 questions on your ability to perform activities of daily living. Examples include; Can you take care of yourself? Can you climb a flight of stairs? You will also be contacted by telephone at 30 days, 6 months, 1 year, and 2 years after your surgery and asked the same 12 questions. If we are unable to reach you by telephone, the questionnaire will be mailed to your home with a return, postage paid envelope included. It should take about 5 minutes to complete. Once you have completed the 2-year questionnaire, your participation in this study will be over.

THIS IS AN INVESTIGATIONAL STUDY. Between 180-200 patients per surgical group will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intrabdominal hyperthermic perfusion, pelvic exenteration, retroperitoneal lymph node dissections, and low anterior resection).

Criteria

Inclusion Criteria:

  1. Patient 18 years of age or older.
  2. Patients scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intrabdominal hyperthermic perfusion, pelvic exenteration, retroperitoneal lymph node dissections, and low anterior resection).
  3. Patients who have signed the consent form to participate in the study.
  4. Patients must have been evaluated in the Preanesthesia Clinic or by a staff Anesthesiologist preoperatively.
  5. All laboratory and diagnostic evaluations required or used to evaluate the patient in the Preanesthesia Clinic must be completed. All patients must be approved for surgery by the standards of the Preanesthesia Clinic.

Exclusion Criteria:

  1. Patient under age 18
  2. Patient is unwilling to sign consent.
  3. Patient is unable to exercise. (Bedridden or wheel chair bound)
  4. Patient is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.
  5. Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation. The patient may reenter the study after reevaluation in the Preanesthesia Clinic and is determined suitable for surgery.
  6. Surgery canceled for any reason. The patient may reenter the study if surgery is rescheduled.
  7. Patient has had a myocardial infarction within 3 month of visiting the Preanesthesia Clinic or presents with new or unstable angina
  8. Patient has a history of a cerebrovascular accident or transit ischemic attacks within 3 month of visiting the Preanesthesia Clinic.
  9. Patient has a history of a pulmonary embolic event within 3 month of visiting the Preanesthesia Clinic.
  10. Patient known to have acute or chronic deep vein thrombosis.
  11. Pregnant patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493688

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Curtis E. Hightower, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00493688     History of Changes
Other Study ID Numbers: 2005-0303
Study First Received: June 27, 2007
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Abdominal Cancer
Pelvic Cancer
Perioperative Energy Dynamics
Cardiopulmonary Exercise Testing
CPET

Additional relevant MeSH terms:
Abdominal Neoplasms
Pelvic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014